Optical sampling interface system for in vivo measurement of tissue

• US 7,206,623 B2
• Filed: 06/12/2002
• Issued: 04/17/2007
• Est. Priority Date: 05/02/2000
• Status: Expired due to Fees

• Current Assignee: GLT Acquisition Corporation
• Original Assignee: Sensys Medical, Inc. (Sensys Medical Limited)
• Inventors: Ruchti, Timothy L., Monfre, Stephen L., Blank, Thomas B., Lorenz, Alexander D., Acosta, George, Mattu, Mutua, Makarewicz, Marcy
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/170,921
• Publication Number:
  US 20030069484A1
• Time in Patent Office: 1,770 Days
• Field of Search: 600309-310, 600322-323, 600/344
• US Class Current: 600/344
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

An optical sampling interface system minimizes and compensates error resulting from sampling variations and measurement site state fluctuations. Components include: An optical probe placement guide having an aperture wherein the optical probe is received, facilitates repeatable placement accuracy on surface of a tissue measurement site with minimal, repeatable disturbance to surface tissue. The aperture creates a tissue meniscus that minimizes interference due to surface irregularities and controls variation in tissue volume sampled; an occlusive element placed over the tissue meniscus isolates the meniscus from environmental fluctuations, stabilizing hydration at the site and thus, surface tension; an optical coupling medium eliminates air gaps between skin surface and optical probe; a bias correction element applies a bias correction to spectral measurements, and associated analyte measurements. When the guide is replaced, a new bias correction is determined for measurements done with the new placement. Separate components of system can be individually deployed.

Claims

1. An optical sampling interface system comprising:

an optical probe placement guide for controlling variations in sample volume;

means for controlling surface reflection of an optical signal;

an occlusion plug for stabilizing surface hydration of a measurement site, said occlusion plug adapted to fit into an aperture in said placement guide between measurements, wherein said occlusion plug is removably attached at an exterior surface of said guide;

wherein sampling error is minimized, eliminated, reduced or compensated.

2. The system of claim 1, wherein said placement guide comprises:

a mount having a contact surface, at least a portion of said contact surface being in contact with a surface proximate said measurement site during use; and

an aperture, defined by said mount;

adapted to receive said optical probe, wherein an area defined by said aperture comprises said measurement site;

wherein said guide is removably attached at said measurement site so that said guide can repeatably couple said optical probe to the measurement site.

3. The system of claim 2, wherein means for attaching said guide comprises any of:

an adhesive;

at least one strap;

at least one armband; and

at least one suction element.

4. The system of claim 2, wherein size and shape of said aperture are matched to those of said optical probe, said probe fitting snugly Into said aperture, so that a mechanical registration in an x-y plane of said probe relative to said measurement site is provided, said guide further comprising at least one mechanical stop, said stop preventing over-penetration of said probe toward said measurement site, and providing registration along a z-axis of said probe relative to said measurement site.

5. The system of claim 2, said guide further comprising optical registration means wherein said probe is registered relative to said measurement site along any of x-, y-, and z-axes.

6. The system of claim 1, said means for controlling surface reflection comprising an optical coupling medium.

7. The system of claim 6, wherein said optical coupling medium comprises an optical coupling fluid.

8. The system of claim 7, wherein said optical coupling fluid comprises:

one or more perfluoro compounds, wherein a quantity of said optical coupling fluid is placed at an interface of an optical probe and a measurement site, so that said probe and said measurement site are tightly optically coupled.

9. The system of claim 1, wherein shape and dimensions of a portion of said occlusion plug adapted to be received by said aperture mimics shape and dimensions of said aperture.

10. The system of claim 1, further comprising means for stabilizing surface temperature.

11. The system of claim 1, wherein said measurement site comprises a tissue measurement site and wherein surface tissue at said measurement site comprises skin, skin surface comprising stratum corneum.

12. The system of claim 11, further comprising means for correcting measurement bias resulting from one or both of variations in sampled volume and measurement conditions.

13. The system of claim 12, wherein said means for correcting measurement bias comprises:

a noninvasive measurement system;

a tissue template; and

a calibration model;

wherein measurement bias is compensated by;

determining difference between a tissue measurement and a tissue template;

mapping resulting difference to a measurement of a target analyte according to a calibration model; and

applying a baseline adjustment to said analyte measurement.

14. The system of claim 13, wherein variations in sampled volume result from differences in placement of either an optical probe, or an optical probe placement guide between measurements.

15. The system of claim 13, wherein said tissue template is determined through one or more tissue measurements combined according to a predetermined data selection criterion during a measurement period.

16. The system of claim 13, wherein said calibration model is determined from a calibration set of exemplary paired data points each consisting of a pre-processed and bias corrected tissue measurement and an associated reference analyte value determined from an analysis of a blood or interstitial fluid sample.

17. The system of claim 13, wherein said baseline adjustment is associated with said tissue template and said calibration model.

18. An apparatus for minimizing optical sampling error at a tissue measurement site due to fluctuations of surface conditions, comprising:

an element defining a probe aperture, wherein said element is fabricated from a flexible material, wherein said element provides for stabilization of the measurement site and deformation of underlying tissue without applying undue force to a targeted tissue volume;

an occlusion plug for insertion into said aperture between measurements; and

means for removably attaching said plug at an exterior surface of said element defining said probe aperture.

19. The apparatus of claim 18, wherein shape and dimensions of at least a portion of said occlusion plug mimic shape and dimensions of said aperture.

20. The apparatus of claim 18, wherein said plug fits snugly within said aperture without additional attachment means.

21. The apparatus of claim 18, wherein said means for attaching comprises any of:

magnets attached to said plug and said apparatus bearing said probe aperture;

hook and loop tape;

adhesives; and

snaps.

22. The apparatus of claim 18, wherein said element bearing said probe aperture induces a tissue meniscus within said aperture.

23. The apparatus of claim 22, wherein said plug is adapted to stabilize hydration level of surface tissue across surface of said meniscus.

24. The apparatus of claim 18, wherein said element defining said aperture comprises an optical probe placement guide.